Quality Engineer- Manufacturing

3 weeks ago


Worcester, United States Azzur Group Full time

DescriptionFrom Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain. Responsibilities:Collaborate with manufacturing engineers to develop manufacturing processes,procedures, and production layouts tailored to assemblies, equipmentinstallation, processing, machining, and material handling in medical devicemanufacturing.Provide support in spearheading and conducting equipment validations,generating comprehensive reports that include IQ, OQ, PQ, and Test MethodValidation.Contribute to the innovation of manufacturing processes aligned with statisticalprocess control, including the development of relevant techniques to enhancequality standards.Offer expertise and guidance to engineering teams on design concepts andspecification requirements to optimize equipment utilization and manufacturingtechniques.Lead the qualification process for new product supplied materials, ensuring thatpurchased products and components meet industry standards, regulatoryrequirements, and customer specifications through thorough qualificationprocedures.Ensure rigorous adherence to regulatory and product quality compliance byoverseeing processes and procedures within the manufacturing environment.Assist in maintaining and revising documentation related to manufacturingoperations, including work instructions, procedures, SOPs, P&ID flows, andassociated change controls within the medical device manufacturing setting.Requirements:Minimum 4 years experienceWorking knowledge of statistical data analysis#LR-KR1


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